Model Number 02.124.417 |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Additional product code: hwc, hrs.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).A manufacturing record evaluation was performed for the not-sterile lot number, and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the photo revealed that 4.5 va-lcp crvd cond pl/16 hole/336/lft is visible at the femur left with signs of bone fracture and the plate was observed to be broken.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for 4.5 va-lcp crvd cond pl/16 hole/336/lft.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
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Event Description
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Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date, a distal femur fracture will be revised on (b)(6)2022.The plate broke at the fracture site.The date of original surgery is currently unknown.There was patient consequence.This complaint involves (1) device 4.5 va-lcp crvd cond pl/16 hole/336/lft.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary : both photo of the device and the actual device itself were received and evaluated.Visual analysis of the photo revealed that 4.5 va-lcp crvd cond pl/16 hole/336/lft is visible at the femur left with signs of bone fracture and the plate was observed to be broken.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 4.5 va-lcp crvd cond pl/16 hole/336/lft was broken across the hole #9 from distal to proximal section.The edges of the broken fragments appear to be smoothed out, most likely due to constant friction before removal.A dimensional inspection for the 4.5 va-lcp crvd cond pl/16 hole/336/lft was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.5 va-lcp crvd cond pl/16 hole/336/lft would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code: 02.124.417, lot no:28p1250: a manufacturing record evaluation was performed for the not-sterile lot number, and no non-conformances were identified.
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Search Alerts/Recalls
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